Trial | NCT01569113  Report issue

Title

Assessment of Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® or Placebo.
A Prospective, Randomized, Double-blind Parallel-arm, Placebo-controlled Study to Assess the Effects on Ovarian Activity of a Combined Oral Contraceptive Pill When Preceded by the Intake of ellaOne® (Ulipristal Acetate 30 mg) or Placebo.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    76
The purposes of this study are to compare the effects on ovarian activity of quick starting a Combined Oral Contraceptive Pill (COCP) after ellaOne® or placebo intake.
Study Started
Mar 31
2012
Primary Completion
Aug 31
2012
Study Completion
Aug 31
2012
Last Update
Jun 13
2013
Estimate

Drug Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)

UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake

  • Other names: ellaOne + Microgynon 30

Drug placebo + ethinylestradiol/levonorgestrel

placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake

  • Other names: Microgynon 30

ellaOne + microgynon 30 Experimental

placebo + microgynon 30 Placebo Comparator

Criteria 

Inclusion Criteria:

Healthy women aged 18-35 years old
BMI < 30 Kg/m2
Not at risk of pregnancy
No use of progesterone-only-pill for 3 months before start of treatment cycle
No use of implant hormonal contraception for 3 months before start of treatment cycle
No use of levonorgestrel intrauterine system for 3 months before start of treatment cycle
No use of depo provera for 12 months before start of treatment cycle
Able to give informed consent.
No Results Posted